Effect of Mycobacterial Infection on Immune Status
EMIIS
1 other identifier
observational
120
1 country
1
Brief Summary
This study, titled "Effect of Mycobacterial Infection on Immune Status" (EMIIS), investigates the immune-driven mechanisms of mycobacterial infections, focusing on the dynamic immune characteristics of multidrug-resistant tuberculosis (MDR-TB), nontuberculous mycobacterial (NTM) infections, and tuberculous pleurisy. Mycobacterial infections (including the Mycobacterium tuberculosis complex and nontuberculous mycobacteria) remain a major global public health threat. EMIIS is a single-center, randomized, single-blind,prospective study. The study recruited 120 participants, divided into groups of healthy individuals/community-acquired pneumonia patients, active pulmonary tuberculosis patients, latent tuberculosis infection patients, tuberculous pleurisy patients, and nontuberculous mycobacteria patients. Blood samples were collected from all groups within 3 days before treatment and 2-3 months after treatment. Pleural effusion samples were additionally collected from the tuberculous pleurisy group within 3 days before treatment and 2 months after treatment. Exhaled breath condensate (EBC) was collected from the nontuberculous mycobacteria group. Utilizing mass cytometry (CyTOF) and multi-dimensional indicators, the study aims to elucidate the immune-driven mechanisms of mycobacterial infections and provide new strategies for individualized treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2025
CompletedFirst Submitted
Initial submission to the registry
May 19, 2026
CompletedFirst Posted
Study publicly available on registry
June 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 20, 2026
June 10, 2026
June 1, 2026
1 year
May 19, 2026
June 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To establish a multi-immune pathway interaction network and composite biomarkers in mycobacterial infection thing
This study utilized mass cytometry (CyTOF) and a pre-designed panel containing 41 metal-tagged antibodies for detection. After data normalization and doublet exclusion, multiple machine learning algorithms were applied for clustering analysis to quantitatively compare the proportions of various immune subsets (such as Th1 cells, Th17 cells, classical monocytes, CD4TEM cells, CD8TEM cells,etc.) among CD45+ leukocytes in the peripheral blood of healthy individuals and patients with active tuberculosis.
3 days before treatment and 2 months after treatment
Secondary Outcomes (8)
Immune cell subsets and mechanisms of possible effects of anti-tuberculosis drugs
3 days before treatment and 2 months after treatment
Differences in immune subsets between normal persons and patients with active pulmonary tuberculosis
3 days before treatment and 2 months after treatment
To explore whether the peripheral blood before treatment contains a certain marker can predict the short-term efficacy
3 days before treatment and 2 months after treatment
Comparison of the dynamic changes of immune subsets in peripheral blood and pleural effusion of TP patients before and after treatment
3 days before treatment and 2 months after treatment
To explore the differences of peripheral blood immune subsets between TP patients and healthy people before treatment
3 days before treatment and 2 months after treatment
- +3 more secondary outcomes
Study Arms (5)
Immunometabolic differences between DS-TB and MDR-TB
Using a prospective, single-center, observational study design, it is planned to enroll 30 patients divided into drug-susceptible tuberculosis and multidrug-resistant tuberculosis. CyTOF technology was used to analyze the differences in immune subsets and metabolic functions.
To assess the effect of immune status on NTM
A total of 15 patients over the age of 18 diagnosed with non-tuberculous mycobacteria were included, and peripheral blood samples were collected after 2 months of treatment to analyze the changes in immune status and metabolic status of non-tuberculous mycobacterial patients in healthy people.
Significance of studying the immunometabolic status of tuberculous pleurisy
A total of 20 patients over the age of 18 diagnosed with tuberculous pleurisy were included in the plan, divided into high-symptom and low-symptomatic groups, and pleural fluid and peripheral blood samples were collected before and after treatment to analyze the changes in their immune status and metabolic status before and after treatment.
Study of immunometabolic status in different states of tuberculosis
A total of 15 patients over the age of 18 diagnosed with active pulmonary tuberculosis and 10 patients with latent pulmonary tuberculosis were enrolled, and peripheral blood samples were collected before and after treatment to analyze the changes in their immune status and metabolic status before and after treatment.
A study of exhaled air condensate in NTM patients versus CAP patients
A total of 30 patients over the age of 18 diagnosed with nontuberculous mycobacteria and 30 healthy or community pneumonia patients were enrolled, and their exhaled air condensate was collected before or within 2 weeks after treatment to analyze its composition.
Eligibility Criteria
Patients with clinical diagnosis including (active tuberculosis, latent tuberculosis, multidrug-resistant tuberculosis, tuberculous pleurisy, nontuberculous mycobacteria), older than 18 years, meeting the inclusion criteria and no exclusion criteria.
You may not qualify if:
- Age ≥ 18 years, all genders and races accepted.
- Patients with active pulmonary tuberculosis diagnosed clinically or by bronchoscopy within less than 1 week.
- Patients with latent tuberculosis infection (positive T-SPOT test but no evidence of active tuberculosis infection).
- Patients with tuberculous pleurisy with onset within less than 1 week.
- Voluntarily join this study and sign the informed consent form.
- Patients whose drug susceptibility test or NGS results indicate resistance to at least isoniazid and rifampicin (MDR-TB).
- Patients whose drug susceptibility test or NGS results indicate sensitivity to first-line anti-tuberculosis drugs.
- Patients whose drug susceptibility test or NGS results indicate resistance to only one anti-tuberculosis drug.
- Patients with newly identified nontuberculous mycobacterial infection (within less than 1 week) by sputum culture or NGS.
- Immunosuppressive conditions including HIV infection, long-term use (\>1 month) of immunosuppressive agents or corticosteroids, severe malnutrition, etc.
- Concurrent other lung diseases, severe liver or kidney dysfunction, severe endocrine diseases, hematological diseases, or malignant tumors that may affect the study outcomes.
- Patients with diabetes mellitus.
- Pregnant or lactating women.
- Patients unable or unwilling to provide informed consent, or with poor compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Ningbo University
Ningbo, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 60 Days
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 19, 2026
First Posted
June 10, 2026
Study Start
July 9, 2025
Primary Completion (Estimated)
July 20, 2026
Study Completion (Estimated)
July 20, 2026
Last Updated
June 10, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share